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FDA 510(k)

Kepler II

K-Number: K163265 · 2017-04-07

ApplicantOrbbo Surgical, LLC
Decision Date2017-04-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kepler II is the device name listed in this FDA 510(k) record. The listed applicant is Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K163265. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kepler II?

Kepler II is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Orbbo Surgical, LLC. The 510(k) number is K163265.

When did Kepler II receive FDA 510(k) clearance?

Kepler II received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163265.

Who is the listed applicant for Kepler II?

The FDA 510(k) record lists Orbbo Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kepler II?

The FDA product code for Kepler II is ODP.

Other records listing Orbbo Surgical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163602Kepler I Cervical Plate SystemK163566Hubble I SystemK163180Hubble II

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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